TGA consultation on therapeutic goods – ear candles, homeopathy

The Therapeutic Goods Administration (TGA) is seeking comments by May 12 on proposed options for future regulation of “low risk” products. These include complementary and alternative medicine products such as aromatherapy, ear candles, homeopathy, and vitamin supplements.

In March 2015, the Expert Review of Medicines and Medical Devices Regulation (MMDR) made recommendations to conduct further reviews of the regulation of “low risk” products in Australia. This approach was supported by Government in its broader consideration of MMDR implementation.

Submissions will cover views on how some CAM products (among others) should be viewed under therapeutic goods regulations: maintain the status quo regulation; exemption from listing in the Australian Register of Therapeutic Goods; excluded from the regulatory framework; or even declared not to be therapeutic goods.

One option specifically for homeopathic products is that “Serious therapeutic claims must be supported by scientific evidence”.

The overall aim of the TGA’s review is to see which “products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act; and goods remaining under the auspices of the Act are subject to regulatory requirements that are commensurate with the risk posed by the regulated products”.

The consultation document can be found here and the submission form can be found here.

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